Biologics

Upcoming CBER Changes Explained

Attorney Maarika Kimbrell (Morgan Lewis) says CBER “is poised for change on a number of important fronts — leadership, significant growth, and plans to address challenging scientific and regulatory issues.” Writing in an online post, Kimbrell says that earlier this year CBER reorganized, establishing an Office of Therapeutic Products (OTP) as a “super-office” within the Center. She says OTP is largely replacing the former Office of Tissues and Advanced Therapies, with the aims of increasing review capacity, expertise, consistency, and discipline alignment.

OTP has three dedicated divisions focused on manufacturing, one for gene therapies, one for cell therapies, and one for other products, including recombinants and plasma protein products. There also are divisions covering clinical, pharm/tox, and regulatory management, the post says.

Kimbrell writes that CBER and OTP are poised for significant growth, as one of the largest areas of growth targeted under PDUFA 7.

She says that while CBER reorganization and growth may work to address the expected and continued increase in INDs and BLAs coming to the Center, significant resources will also be required to address commitments under PDUFA 7 and growth in CBER’s Regenerative Medicine Advanced Therapy program and to make progress toward the ambitious goal CBER has recently set.

The post discusses the goals and several policy advances being sought by CBER leadership, including Center director Peter Marks.

“It is worth noting that none of these scientific or policy questions are straightforward and while Dr. Marks is right that progress is needed on these fronts to adequately support the development of new and needed technologies, these thorny issues add to CBER’s already long list of promised deliverables,” Kimbrell concludes. OTP director Nicole Verdun and others in CBER leadership “will have the significant task of bringing these advancements to a reality, which includes ensuring that these goals are met at the review level of individual applications. In an era with anticipated evolution of scientific and regulatory approaches, coupled with significant growth in CBER’s staff and leadership, heightened coordination with CBER and clear communication with FDA will be significant factors for success moving forward.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome